The American Society of Clinical Oncology has endorsed the guideline on molecular testing of epidermal growth factor receptor and anaplastic lymphoma kinase tyrosine kinase inhibitors that was issued jointly last year by the College of American Pathologists (CAP) and the International Association for the Study of Lung Cancer (IASCLC)/Association for Molecular Pathology (AMP) (OT 5/25/13 issue).
ASCO's endorsement statement is now online ahead of print in the Journal of Clinical Oncology (doi: 10.1200/JCO.2014.57.3055).
The guideline defines which patients should be offered EGFR and ALK genetic testing, and when and how such testing should be performed.
“Given the impact of targeted therapies in patients with EGFR-mutated and ALK-positive non-small-cell lung cancer, it is important to make sure that we routinely perform molecular analysis of the tumor specimens,” said Ramaswamy Govindan, MD, OT's Clinical Advisory Editor, a lung cancer specialist who is Professor of Medicine and Co-Director of the Section of Medical Oncology at Washington University School of Medicine Alvin J Siteman Cancer Center.
“I believe this is just the beginning; eventually we may have to test the genomic alterations more comprehensively.”
And, said Natasha B. Leighl, MD, MSc, Co-chair of ASCO's Expert Panel that endorsed the guideline, “ASCO's endorsement provides doctors much-needed direction in a rapidly moving field. This guideline is incredibly important, as it increases the ability to personalize lung cancer care and improve outcomes for patients with advanced lung cancer.”
The document describes the current evidence and helps oncologists and pathologists understand and put molecular testing into clinical practice, she said in a news release.
Several targeted treatment options are now available for patients with advanced non-small-cell lung adenocarcinoma, the most common subtype of lung cancer, she noted. These treatments, including EGRF-targeting drugs erlotinib and afatinib and ALK-targeting drugs crizotinib and ceritinib, can shrink tumors and slow disease progression—but they work only in patients with the specific changes in the EGFR or ALK genes.
“Prompt and reliable molecular testing is critical for ensuring that all patients who are candidates for such therapy are identified.”
Added the panel's other Co-Chair, Natasha Rekhtman, MD, PhD: “This guideline will help standardize which patients are tested and when and how the testing is implemented. We hope it will encourage testing and treatment based on molecular results.”
The guideline comprises 37 recommendations, expert consensus opinions, and suggestions, including the following:
- Offer EGFR and ALK testing to all patients with lung adenocarcinoma (or mixed lung cancers with adenocarcinoma component), irrespective of characteristics such as gender, race, and smoking status.
- Laboratories can use a range of different testing methods, provided they meet certain technical requirements. Certain types of tests are not recommended.
- Laboratories should adhere to guidance regarding specimen processing, testing validation, quality assurance, and turnaround times for reporting results.
The news release notes that CAP, IASLC, and AMP are currently updating their guideline based on new evidence regarding ALK testing, testing for molecular alterations associated with acquired resistance to EGFR and ALK inhibitors; new markers such as ROS1, RET, ERBB2 (HER2), BRAF, MET, and next-generation sequence testing, and that ASCO Expert Panel members will work with their CAP, IASLC, and AMP counterparts to keep abreast of substantive updates to the current lung cancer testing guideline and determine the need to update the ASCO endorsement.